Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

NCT03029130 | Unknown DMC

• 1 other identifier: EvangelWFC
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.

Conditions

Vesico Vaginal Fistula

Keywords

vesicovaginal fistula; urinary catheter; catheter extension

Outcome Measures

Primary Outcomes (1)

• Fistula closure

  Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak

  3 months post-repair

Secondary Outcomes (3)

• Urinary continence

  3 months post-repair

• Closure and continence at hospital discharge

  Date of discharge (7-28 days post-repair)

• Complications

  Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)

Study Arms (2)

Catheter Extension

EXPERIMENTAL

Patients in this arm will have a foley catheter re-passed, to remain in situ for an additional 14 days, after which time the catheter will be removed and the patient discharged to return for follow up exam at 3 months postop.

Device: Catheter extension

Discharge

NO INTERVENTION

Patients in this arm will be discharged, to return for follow up exam at 3 months postop.

Interventions

Catheter extension DEVICE

Foley transurethral catheter placed to allow continuous drainage of urine.

Catheter Extension

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test

You may not qualify if:

• HIV infection,
• concomitant bladder stone(s),
• one or more ureters outside of the bladder,
• urethrovaginal fistula,
• multiple fistulas (more than one),
• dye leak / fistulous leak present at end of surgical procedure,
• radiation-induced fistula,
• fistula caused by cancer or infection (such as lymphogranuloma venereum),
• continence procedures being performed (such as pubovaginal sling),
• rectovaginal fistula,
• pregnancy,
• fistula breakdown of greater than 2cm identified on postoperative dye test.

Sponsors & Collaborators

• Evangel VVF Centre: lead

MeSH Terms

Conditions

Vesicovaginal Fistula

Condition Hierarchy (Ancestors)

Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Fistula; Urinary Fistula; Urogenital Abnormalities; Urinary Bladder Diseases; Urologic Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fistula Surgeon

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share